WC500185968

also advised requesting the input from the SAG HIV/viral diseases on whether current evidence on
lactic acidosis with NRTIs supports a differential risk within the class.
Further PRAC advice will be provided following submission of the MAHs’ responses and their
assessment.
10.3.2. Epoetins:
Darbepoetin alfa – ARANESP (CAP);
Epoetin alfa – ABSEAMED (CAP), BINOCRIT (CAP), EPOETIN ALFA HEXAL (CAP);
Epoetin beta – MIRCERA (CAP), NEORECORMON (CAP);
Epoetin theta – BIOPOIN (CAP), EPORATIO (CAP);
Epoetin zeta – RETACRIT (CAP), SILAPO (CAP)
PRAC consultation on post-authorisation measures, upon CHMP request
Regulatory details:
PRAC Rapporteur (overall): Valerie Strassmann (DE)
PRAC Co-Rapporteurs: Arnaud Batz (FR), Dolores Montero Corominas (ES)
Administrative details:
Procedure number(s): EMEA/H/C/000332/LEG 083.4 (Aranesp), EMEA/H/C/000727/LEG 023.4
(Abseamed), EMEA/H/C/000725/LEG 022.4 (Binocrit), EMEA/H/C/000726/LEG 023.4 (Epoetin Alfa
Hexal), EMEA/H/C/000739 LEG 032.4 (Mircera), EMEA/H/C/000116/LEG 049.4 (NeoRecormon),
EMEA/H/C/001036/LEG 019.4 (Biopoin), EMEA/H/C/001033/LEG 019.4 (Eporatio),
EMEA/H/C/000872/LEG 036.4 (Retacrit), EMEA/H/C/000760/LEG 035.4 (Silapo)
Scope: Erythropoiesis-stimulating agents (ESA): Evaluation of the outcome of statistical analysis of
clinical trial data in chronic kidney disease (CKD) patients on dialysis/not on dialysis (treatment of
anaemia)
MAH(s): Amgen Europe B.V. (Aranesp), Medice Arzneimittel Pütter GmbH & Co. KG (Abseamed),
Sandoz GmbH (Binocrit), Hexal AG (Epoetin Alfa Hexal), Roche Registration Ltd (Mircera,
NeoRecormon), CT Arzneimittel GmbH (Biopoin), Ratiopharm GmbH (Eporatio)
Background
For background, see PRAC Minutes February 2015.
Summary of advice and conclusion(s)
Based on the review of all available information, the PRAC advised requesting MAHs to revise their
product information, in order to ensure that the lowest approved effective dose is used to provide
adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below
or at 12 g/dl (7.45 mmol/l), together with adequate warnings.
In terms of communication, the PRAC did not support the distribution of a DHPC as the issue of nonresponders
is well known and clinical practice guidelines in the field (Kidney Disease Improving Global
Outcomes (KDIGO)) have since 2012 already addressed the non-responders problem. The PRAC
recommended alternative ways of communication including communication to HCPs through the
Healthcare Professionals Working Party (HCPWP) as well as the possibility of dialogue with the
European Renal Best Practice (ERBP) under the aegis of the European Renal Association-European
Dialysis Transplantation Association (ERA-EDTA).
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 52/89